SESSION TITLE: COPD Posters V
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: Inhaled long-acting bronchodilators are the mainstay of COPD pharmacological management. Once-daily glycopyrronium 50 µg (GLY) is a fast-onset long-acting muscarinic antagonist approved for maintenance bronchodilator treatment in patients with COPD in more than 80 countries including countries within the EU and Latin America, Canada and Switzerland. Previously, GEM1 and GEM2 studies showed improvements in lung function, dyspnea, and health status with twice-daily GLY 12.5 μg versus placebo. Here we explore the effect of GLY on lung function in the pooled data from these studies.
METHODS: GEM1 and GEM2 were replicate, 12-week, multicenter, double-blind, placebo-controlled studies which randomized COPD patients with moderate-to-severe airflow limitation to twice-daily GLY 12.5 μg or placebo (1:1) delivered via the NeohalerTM device. Data from these studies were pooled for change from baseline in time weighted mean area under curve between 0-12 h for FEV1 (AUC0-12h) post-morning dose at Week 12. Trough FEV1, onset of action and peak FEV1 were also evaluated.
RESULTS: Data from 867 patients from the GEM1 and GEM2 studies (GLY, n=437; placebo, n=430) were pooled and analyzed. Compared to placebo, GLY showed a statistically significant and clinically meaningful improvement in FEV1AUC0-12h (least squares mean treatment difference [Td]: 0.129L, 95% CI: 0.099, 0.160, p<0.001), and significant increase from baseline in trough FEV1 (Td: 0.099L, 95% CI: 0.067, 0.131, p<0.001) at Week 12. GLY showed a significant improvement in FEV1 as early as 5 min post-dose (Td: 0.060L, 95% CI: 0.046, 0.074, p<0.001), and clinically meaningful significant improvement at 15 min post-dose (Td: 0.112L, 95% CI: 0.097, 0.128, p<0.001) on Day 1, compared with placebo. Significant improvement in FEV1 with GLY versus placebo was seen at all time-points assessed on Day 1 and at Week 12 from 0 to 12 h post-dose (p<0.001). Improvements in peak FEV1 during the first 4 h post-morning dose were statistically significant with GLY versus placebo on Day 1 (Td: 0.139L, 95% CI: 0.120, 0.159, p<0.001) and at Week 12 (Td: 0.154L, 95% CI: 0.121, 0.186, p<0.001).
CONCLUSIONS: Significant improvements across several measures of lung function were seen with twice-daily glycopyrronium 12.5 μg compared with placebo in COPD patients with moderate-to-severe airflow limitation.
CLINICAL IMPLICATIONS: These findings support the usage of twice-daily glycopyrronium 12.5 μg as an effective treatment option for COPD patients with moderate-to-severe airflow limitation.
DISCLOSURE: Edward Kerwin: Consultant fee, speaker bureau, advisory committee, etc.: Has served on advisory boards, speaker panels, or received travel reimbursement for Novartis Pharmaceuticals., Grant monies (from industry related sources): Received grant monies to conduct multicenter clinical research trials for approximately forty pharmaceutical companies including Novartis. Selwyn Spangenthal: Grant monies (from industry related sources): Received honoraria from AstraZeneca, Forest, Mylan Labs, and Novartis S. David Miller: Grant monies (from industry related sources): Research grant from Novartis Peter D’Andrea: Employee: Employee of the study sponsor, Novartis and no other conflicts Joerg H. Eckert: Employee: Employee of the study sponsor, Novartis and no other conflicts Michelle Henley: Employee: Employee of the study sponsor, Novartis and no other conflicts Francesco Patalano: Employee: Employee of the study sponsor, Novartis and no other conflicts
No Product/Research Disclosure Information